Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in adult patients diagnosed with type 1 diabetes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NextCell Pharma Ab

Criteria

Inclusion Criteria:

1. Written informed consent for participation of the study, given before undergoing any study-specific procedures

2. Clinical history compatible with type 1 diabetes diagnosed less than 2 years before enrolment

3. In the first part of the study patients 1-6 only male patients between 18-40 years of age will be included. In the second part of the study, patients 7-21, both male and female patients 18 to 40 years of age (inclusive at both ends) will be included.

4. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol

5. Fasting plasma C-peptide concentration >0.12 nmol/L.

6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in "Recommendations related to contraception and pregnancy testing in clinical trials", supplied from www.hma.eu/):

1. Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.

• oral

• intravaginal

• transdermal

2. progestogen-only hormonal contracption associated with inhibition of ovulation

• oral

• injectable

• implantable

3. intrauterine device (IUD)

4. intrauterine hormone-releasing system (IUS)

5. bilateral tubal occlusion

6. total abstinence or vasectomized partner.

Exclusion Criteria:

1. Inability to provide informed consent

2. Patients with body mass index (BMI) > 30, or weight >100 kg

3. Patients with weight <50 kg

4. Patients with unstable cardiovascular status incl. NYHA class III/IV

5. Patients with active infections unless treatment is not judged necessary by the investigators

6. Patients exposed to tuberculosis or has travelled in areas with high risk of tuberculosis or mycosis within the last 3 months

7. Patients with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.

8. Patients with any immune suppressive treatment

9. Patients with known demyelinating disease

10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test

11. Patients with known, or previous, malignancy.

12. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin

13. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.

14. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).